FDAnews
www.fdanews.com/articles/108471-angiodynamics-recalls-centros-catheter

AngioDynamics Recalls Centros Catheter

July 11, 2008

AngioDynamics is voluntarily recalling all hospital inventory of Centros, its self-centering central venous catheter for dialysis.

The catheter cuff, which anchors the catheter in subcutaneous tissue, was inadequately attached in some instances, allowing movement of the catheter in the insertion site, leakage around the site and retention of the cuff in the tissue when the catheter is removed.

AngioDynamics has traced the problem to an outside manufacturer’s production process. Pending an FDA review, shipments of Centros are expected to resume after Dec. 1. The company has shipped roughly 1,500 Centros catheters since January.